IEEE Std 1708a:2019 pdf free download – IEEE Standard for Wearable, CufflessBlood Pressure Measuring Devices
4.3.1 Subject selection requirements for normal adult population
The summarized requirements on subject selection are presented in Table 1.Forty-five At least eighty-five(85 ) subjects, with at least 22 26 females and 22-4226 males, aged between 1821 years and 6550 years oldshall be recruited if the device is intended for adult use. The study participants are to be introduced to theobservers, who will explain to them the eligibility requirements and specific procedures. Initials, sex, dateof birth,medical history and current medications are to be recorded on the case report form. Pregnant,pediatric,or elderly people, or those with present arrhythmias,should not be included in the study. If awearable,cuffless BP measuring device’s intended use is not limited to the population described by thesubject selection requirements in 4.3.1 , additional performance evaluation shall be conducted according to4.3.3.The intended use population is determined by reviewing the instructions for use.
The subjects shall also have a specified range of BP.The endpoint of the BP classification is determinedaccording to the JNC 7 report [B5]. The BP used in the analysis should be the entry BP measured by atrained observer following the recommendation called out by BHS protocol [B21]. Three measurements arerequired at the sitting position, and the averaged value is used as the entry BP to determine the subject’s BPclassification.
lf a wearable, cuffless BP measuring device uses patient-specific parameters (height, weight, sex, age, etc.)in the calculation of BP, each patient-specific parameter used in the calculation should be recorded in thecase report form. The range of each parameter from the study participants should cover the expectedpopulation during device use.The device accuracy for patient-specific parameters should be presented inTable 6 where a row should be included for each patient-specific parameter used in the BP calculation.
4.4.1 Introduction
Change text in 4.4.1 as follows:
As recommended by the ESH protocol [B23], the overall outcome of a device can be apparent from a veryearly stage. To avoid the unnecessary waste of time and money， and an inconvenience to subjects,thevalidation process is divided into two phases. In Phase 1, only 20 subjects are recruited, and any devicefailing this phase should be eliminated from further testing. Devices passing Phase 1 test will proceed toPhase 2 in which at least 65 additional subjects are required.Hence,the complete validation procedureswill be conducted in a total of 85 subjects，as specified in the ANSI/AAMI SP10 and ISO 81060-2standards; with at least 255 BP determinations having a mean error magnitude ≤ 5 mmHg and a standarddeviation ≤ 8 mmHg. Those passing devices will proceed to Phase 2 in which another 65subjeets arerecruited.
The validation may proceed to Phase 2 only if the test device passes accuracy criteria in Phase 1 (see 4.5.2);if not, the device should be climinated from further testing.Correlation between errors in measurementsfrom the same subject is considered after Phase 1 to determinc if additional subjects (more than 65) may beneeded in Phase 2, see 4.5.3.
Two test devices should be randomly chosen from the device pool. Those two devices should be usedthrough the whole validation procedure with each device completing validation on at least 22 42 subjects.
Concerning the special feature of the cuffless BP measuring devices, where the calibration efficacy wouldgreatly influence the device accuracy, the validation procedures are considerably different from that of thecuff-based devices.For each subject, the procedure is broken down into three levels: static test, test withBP change from the calibration point, and test after a certain period of time from calibration.Practitionersshould properly design their validation protocol to cover the validation from each of the three levels.